Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

The Ohio State University

Status: Completed

Conditions: Breast Neoplasms; Arthralgia

Treatments: Dietary Supplement: Omega-3 Fatty Acid; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02831582

OSU-15222

NCI-2016-00377 (Registry Identifier)

Details and patient eligibility

About

This clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.

Full description

PRIMARY OBJECTIVES:

I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs).

SECONDARY OBJECTIVES:

I. To prospectively define the population most at risk for developing AIIAs by the identification and validation of genetic risk predictors and to develop a single nucleotide polymorphism (SNP)/gene profile predictive of treatment intervention response.

OUTLINE: Patients are randomized to 1 of 2 groups.

Group I: Patients receive omega-3 fatty acid supplementation orally (PO) once daily (QD) for 6 months.

Group II: Patients receive placebo PO QD for 6 months.

After completion of study, patients will be followed up periodically.

Enrollment: 75 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole)
• Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed.
• Prior tamoxifen use is allowed
• Prior chemotherapy is allowed
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Metastatic malignancy of any kind
• Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease
• AI use > 21 days prior to study enrollment
• Known bleeding disorders
• Current use of warfarin or other anticoagulants
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
• Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
• Pregnant or nursing women
• Known sensitivity or allergy to fish or fish oil
• Unable to give informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

Arm I (omega-3 fatty acid)

Active Comparator group

Description:

Patients receive omega-3 fatty acid supplementation PO QD for 6 months.

Treatment:

Dietary Supplement: Omega-3 Fatty Acid

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO QD for 6 months.

Treatment:

Other: Placebo